Prescription drug · ANDA
Ashlyna NDC 50090-2097
levonorgestrel and ethinyl estradiol and ethinyl estradiol · Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2097-0 | 50090209700 | 1 KIT in 1 KIT (50090-2097-0)Marketed from Oct 12, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ashlyna
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203163
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-2097_dfa0a295-8eca-42c0-a8c2-c2cec0eacfd2SPL ID dfa0a295-8eca-42c0-a8c2-c2cec0eacfd2SPL set ID 2004a53d-3f62-4c33-813a-94b1567fe465RxCUI 238019, 248310, 749761, 1603861
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090209700followed by a unit qualifier and the quantityPackage 50090-2097-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Ashlynais indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203163
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ashlynalevonorgestrel and ethinyl estradiol and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-646 |